Date Initiated by Firm | December 18, 2024 |
Date Posted | January 16, 2025 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0905-2025 |
Recall Event ID |
95898 |
510(K)Number | K912120 |
Product Classification |
Choledochoscope and accessories, flexible/rigid - Product Code FBN
|
Product | Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891.
This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories. |
Code Information |
Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
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Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy Center Valley PA 18034-8229
|
For Additional Information Contact | Cynthia Ow 647-9993203 |
Manufacturer Reason for Recall | Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device. |
FDA Determined Cause 2 | Labeling design |
Action | Olympus notified consignees on about 12/18/2024 via letter. Consignees were instructed to utilize alternative devices to the MAJ-891 according to the provided compatibility table provided, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this letter and the MAJ-891 reprocessing instructions, acknowledge receipt of the letter through the Olympus portal, https://olympusamerica.com/recall, and notify customers if the units have been further distributed. Additionally, Olympus will contact customers to schedule a mutually beneficial time for an Olympus Field Representative to visit each facility and review the contents of this letter and the MAJ-891 reprocessing instructions. |
Quantity in Commerce | 30,140 units |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = FBN
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